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AIDS Therapeutics Toxicity Studies Program

Infection with human immunodeficiency virus (HIV) causes immunosuppression and leads to acquired immunodeficiency syndrome (AIDS) with a broad spectrum of opportunistic infections. Prophylaxis and treatment of AIDS are generally combination therapies of antiretroviral agents with antimicrobial drugs specific for the opportunistic infections. The National Institute of Environmental Health Sciences (NIEHS), under the AIDS research program, collaborates with other institutes of the NIH, other government agencies, and pharmaceutical companies to evaluate the reproductive/developmental toxicity, general toxicity, immunotoxicity and neurotoxicity of AIDS therapeutics. These evaluations may include single therapeutic agents or combination therapies when the toxic potential of these agents in animal models is not available or is incomplete. The studies with combination therapies are very important in that they will increase awareness and understanding of interactions between antiretroviral therapies and other drugs/substances that HIV-infected individuals may be using.

AIDS Publication Abstracts
  • National Toxicology Program. 2013. NTP Report on the Toxicology and Carcinogenicity Studies of 3'-Azido-3'-Deoxythymidine (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In utero and Postnatal Gavage Studies). Research Triangle Park, NC: National Toxicology Program. (GMM-14):1-238.
  • National Toxicology Program. 2013. NTP Report on the Toxicology and Carcinogenicity Study of Mixtures of 3′-Azido-3′-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRN 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies). Research Triangle Park, NC: National Toxicology Program. (GMM-16):1-202.
  • National Toxicology Program. 2006. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Transplacental AZT (CASRN 30516-87-1) in Swiss (CD-1®) Mice (In utero Studies). Research Triangle Park, NC: National Toxicology Program. (TR-522):1-186.
  • National Toxicology Program. 1999. NTP Technical Report on Toxicology and Carcinogenesis Studies of AZT (CASRN 30516-87-1) and AZT/ a-Interferon A/D B6C3F1 Mice (Gavage Studies). Research Triangle Park, NC: National Toxicology Program. (TR-469):1-361.
  • Ghanta N. Rao, Charles Lindamood III, James E. Heath, Daniel R. Farnell, and Hirschell D.Giles. Subchronic Toxicity of Human Immunodeficiency Virus and Tuberculosis Combination Therapies in B6C3F1 Mice. Toxicological Sciences; 45, 113-127 (1998).
  • Rao GN, Collins BJ, Giles HD, Heath JE, Foley JF, May RD, Buckley LA. Carcinogenicity of 2',3'-Dideoxycytidine in Mice. Cancer Res; VOL 56, ISS 20, 1996, P4666-72.
  • Sanders VM, Elwell MR, Heath JE, Collins BJ, Dunnick JK, Rao GN, Prejean D, Lindamood C III, Irwin RD. Induction of Thymic Lymphoma in Mice Administered the Dideoxynucleoside ddC. Fundamental and Applied Toxicology; 27 (2). 1995. 263-269.
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NIEHS AIDS Therapeutics Toxicity Reports
AIDS Abstract Full Text Report Title Report Date
AIDS-09 PDF (5MB) NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-deoxythymidine (AZT) and Clarithromycin Combinations (CASRNs 30516-87-1 and 81103-11-9) Administered by Gavage to Swiss (CD-1®) Mice 2003
AIDS-08 PDF (4MB) NIEHS Technical Report on the 13-Week Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Isoniazid Combinations (CASRNs 30516-87-1 and 54-85-3) Administered by Gavage to B6C3F1 Mice 2002
AIDS-07 PDF (5MB) NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Pyrazinamide Combinations (CASRNs 30516-87-1 and 98-96-4) Administered by Gavage to Swiss (CD-1®) Mice 2002
AIDS-06 PDF (6MB) NIEHS Technical Report on the Subchronic Toxicity Study of 3'-Azido-3'-dioxythymidine (AZT) and Rifampicin Combinations (CASRNs 30516-87-1 and 13292-46-1) Administered by Gavage to B6C3F1 Mice 2001
AIDS-05 PDF (3MB) NIEHS Technical Report on the Subchronic Toxicity Study of 3'-Azido-3'-dioxythymidine (AZT) and Pyrazinamide Combinations (CASRNs 30516-87-1 and 98-96-4) Administered by Gavage to B6C3F1 Mice 1999
AIDS-04 PDF (6MB) NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Study of 3'-Azido-3'-deoxythymidine (AZT) and Rifabutin Combinations (CASRNs 30516-87-1 and 72559-06-9) Administered by Gavage to Swiss (CD-1®) Mice 2000
AIDS-03 PDF (2MB) NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-dioxythymidine (AZT) and Isoniazid Combinations (CASRNs 30516-87-1 and 54-85-3) Administered by Gavage to Swiss (CD-1®) Mice 1999
AIDS-02 PDF (5MB) NIEHS Technical Report on the Reproductive, Developmental, and General Toxicity Studies of 3'-Azido-3'-dioxythymidine (AZT), Trimethoprim (TMP)/ Sulfamethoxazole (SMX), and Folinic Acid Combinations Administered by Gavage to Swiss (CD-1®) Mice 1998